Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors (NCT04557449)
A PHASE 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy. The study consists of two parts and a China and Japan monotherapy cohort. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide. In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively). In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from the Part 1A will be conducted In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI) In Part 1F, escalating dosed of PF-07220060 will be administered in combination with enzalutamide Part 1B and Part 1C may commence at MTD or before reaching the MTD at a dose level in Part 1A. Part 2A is a dose expansion cohort with fulvestrant and will explore more than one dose of PF-07220060 in participants diagnosed with mBC. Part 2B and Part 2C are expansion for combination therapy of PF-07220060 with letrozole and fulvestrant, respectively. Part 2D is the expansion cohort for combination therapy of PF-07220060 with enzalutamide. Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy. The China monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as single agent in Chinese participants. The Japan monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as a single agent in Japanese participants.
Who can join: Review the eligibility criteria below.
Location: Ellison Institute — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (39 Sites)
Showing the first 25 of 39 sites.
- Ellison Institute — Los Angeles, California
- Smilow Cancer Hospital - Yale New Haven Health — New Haven, Connecticut
- Yale-New Haven Hospital-Yale Cancer Center — New Haven, Connecticut
- Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut
- Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP — New Haven, Connecticut
- Smilow Cancer Hospital - Trumbull — Trumbull, Connecticut
- Brigham & Women's Hospital — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Dana Farber Cancer Institute- Chestnut Hill — Newton, Massachusetts
- START Midwest — Grand Rapids, Michigan
- Sarah Cannon Research Institute - Pharmacy — Nashville, Tennessee
- SCRI Oncology Partners — Nashville, Tennessee
- The University of Texas MD Anderson Cancer Center — Houston, Texas
- The University of Texas, MD Anderson Cancer Center - West Houston — Houston, Texas
- Hospital Británico de Buenos Aires — Ciudad Autónoma de Buenos Aires, Buenos Aires
- Fundación Cenit Para La Investigación En Neurociencias — CABA, Ciudad Autã³noma de Buenos Aires
- Fundación Respirar — Buenos Aires,
- Clínica Universitaria Reina Fabiola — Córdoba,
- Fundación CORI para la Investigación y Prevención del Cáncer — La Rioja,
- Cancer Hospital Chinese Academy of Medical Science — Beijing, Beijing Municipality
- Henan Cancer Hospital — Zhengzhou, Henan
- Hubei Cancer Hospital — Wuhan, Hubei
- The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang
- Vseobecna fakultni nemocnice v Praze — Prague,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Liposarcoma
- BTX-A51 in Patients With Liposarcoma or CIC-rearranged Sarcoma — Boston, Massachusetts
- Eribulin and Radiation Therapy in Treating Patients With Retroperitoneal Liposarcoma That Can Be Removed by Surgery — Portland, Oregon
- Investigating Engagement Patterns and Participation Trends Among Liposarcoma Patients — San Francisco, California
Explore by condition: All Liposarcoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.